The country of origin of Mirtazapine Orally Disintegrating Tablets

N330010 January 23, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Prakash Rajendran Viona Pharmaceuticals Inc 20 Commerce Drive, Suite 340Cranford, NJ 07016 RE: The country of origin of Mirtazapine Orally Disintegrating Tablets Dear Mr. Rajendran: In your letter dated December 27, 2022, you requested a country of origin ruling of Mirtazapine Orally Disintegrating Tablets. Mirtazapine, imported in 15 mg, 30 mg, and 45 mg orally disintegrating tablets, belongs to a group of medicines called tetracyclic antidepressants. It is indicated for the treatment of major depressive disorder. You stated that the active pharmaceutical ingredient (API), Mirtazapine, is manufactured in Spain, and that the finished Mirtazapine Orally Disintegrating Tablets in dosage form are made in Bangladesh.  In Bangladesh, the Mirtazapine will be mixed with various inactive ingredients to produce the final Mirtazapine Orally Disintegrating Tablets in dosage form.  Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: The country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; …. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Mirtazapine (made in Spain) with the inactive ingredients into the final dosage tablets in Bangladesh does not result in a substantial transformation and the country of origin will be Spain. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division